Devices and methods for delivering a beneficial agent to a user

ABSTRACT

Drug delivery reservoir cassette for a pump is provided. The cassette includes a cassette housing having a front surface, a back surface and lateral sidewalls, the cassette housing defining a transverse axis extending between the lateral sidewalls and a longitudinal axis perpendicular to the transverse axis. The cassette housing includes a cassette body region defining a fluid reservoir chamber therein, and a cassette base region having a boundary configured to be received by the pump, the boundary including a pair of opposing rails disposed on opposite sides of the longitudinal axis. The cassette base region can also include an engagement surface, alignment key, and/or support rib to align the cassette in a receiving region of the pump. A device for delivering a beneficial agent including a pump and cassette is also provided.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Provisional Patent ApplicationNos. 61/922,721, filed Dec. 31, 2013; and 62/054,153, filed Sep. 23,2014; each of which is incorporated by reference herein in its entirety.

BACKGROUND

1. Field of the Disclosed Subject Matter

The disclosed subject matter relates to devices, systems and methods forcontrolling and delivering fluids, for example for delivery of abeneficial agent to a user.

2. Description of Related Art

A variety of fluid transport devices and systems have been developed forcontrolling and delivering beneficial agents in fluid form. Such fluidflow systems can include 1) volumetric-based aspiration flow systemsusing positive displacement pumps, and 2) vacuum-based aspirationsystems using a vacuum source. For example, volumetric aspirationsystems include peristaltic pumps for the delivery of therapeutic agentsto a user. Various forms of peristaltic pumps are known, such as usingrotating rollers to press against a flexible tubing to induce flowtherethrough. Cassette systems or other reservoir configurations can becoupled with the pump to provide a source of beneficial agent fluid viathe flexible tubing.

Such devices and systems are particularly beneficial as portableinfusion pumps capable of being worn or carried by the user. However,there remains a need for improvement of such devices and systems. Suchimprovements include, among other things, improved energy consumptionand battery life, improved pump efficiency and control, improved comfortand ergonomics, and improved cassette configuration for more completeaccess to the reservoir contents.

SUMMARY

The purpose and advantages of the disclosed subject matter will be setforth in and apparent from the description that follows, as well as willbe learned by practice of the disclosed subject matter. Additionaladvantages of the disclosed subject matter will be realized and attainedby the methods and systems particularly pointed out in the writtendescription and claims hereof, as well as from the appended drawings.

To achieve these and other advantages and in accordance with the purposeof the disclosed subject matter, as embodied and broadly described, thedisclosed subject matter includes a drug delivery reservoir cassette fora pump, the pump having a lock member movable between an open positionand a closed position. The cassette generally includes a cassettehousing including a cassette body region and a cassette base region. Thecassette housing has a front surface, a back surface and lateralsidewalls. The cassette housing defines a transverse axis extendingbetween the lateral sidewalls and a longitudinal axis perpendicular tothe transverse axis. The cassette body region defines a fluid reservoirchamber therein. As embodied herein, for purpose of illustration and notlimitation, the cassette base region can be disposed along thelongitudinal axis from the cassette body region. The cassette baseregion has a boundary configured to be received by the pump. Asdisclosed herein, the cassette base region can include one or morefeatures, alone or in combination, to align and secure the cassette whenreceived by the pump.

In accordance with one aspect of the disclosed cassette base region, theboundary can include a pair of opposing rails disposed on opposite sidesof the longitudinal axis. As embodied herein, the pair of opposing railscan be substantially symmetrical about the longitudinal axis. Each ofthe opposing rails can be recessed relative an adjacent portion of theboundary. The pair of opposing rails can be aligned along a transverseaxis relative the longitudinal axis. Each of opposing rails can definean abutment surface generally parallel with the transverse axis.

Furthermore, and as embodied herein, the cassette base region caninclude an engagement surface configured to be engaged by the lockmember when in the closed position. The pair of rails can be spaced fromthe engagement surface in a direction along the longitudinal axis. Theboundary can also include an alignment key aligned parallel with thelongitudinal axis and can define a receiving recess to receive analignment pin from the pump. The alignment key can be spaced from thepair of rails and from the engagement surface in a direction along thelongitudinal axis. The cassette can further include a delivery tubeassembly extending from the fluid reservoir chamber, and the cassettebase region can include a support rib projecting from the boundary inengagement with the delivery tube. The cassette base region can includea flat surface proximate an end of the cassette housing. The flatsurface can include two flat surface portions. Additionally oralternatively, the cassette base region can include a contoured surfaceconfigured to mate a corresponding surface of the pump. For example, thecontoured surface can have a concave shape directed toward the boundaryin plan view. The contoured surface can be substantially symmetricalabout the longitudinal axis.

According to another aspect of the disclosed cassette, the cassette baseregion can include an engagement surface configured to be engaged by thelock member when in the closed position. The engagement surface can besubstantially coplanar with the back surface of the cassette housing.Alternatively, the engagement surface can include a recessed arearecessed relative the back surface of the cassette base region. Therecessed area can be shaped to receive the lock member when in theclosed position. As embodied herein, the recessed area can taper to areduced or smaller cross dimension in plan view toward an end of thecassette housing.

Furthermore, and as embodied herein, the engagement surface can includea pair of engagement surface portions on opposite sides of thelongitudinal axis. The pair of engagement surface portions can besubstantially symmetrical about the longitudinal axis. The engagementsurface can include an elongated strip. The engagement surface caninclude a unitary bridge across the longitudinal axis. Additionalfeatures of the cassette as disclosed herein can be combined with theengagement surface of this aspect.

According to another aspect of the disclosed cassette as set forthabove, the cassette base region can include an alignment key alignedparallel with the longitudinal axis and defining a receiving recess toreceive an alignment pin from the pump. The alignment key can becentered between the lateral side walls. The alignment key can projectfrom the cassette body region into the cassette base region, andparticularly, the alignment key can project into the boundary. Thealignment key can be channel-shaped to define the receiving recess.Additionally or alternatively, the receiving recess can be tapered alongthe longitudinal axis. Additional features of the cassette as disclosedherein can be combined with the alignment key of this aspect.

According to another aspect of the disclosed cassette as set forthabove, a delivery tube assembly can be provided extending from the fluidreservoir chamber. The cassette base region can include a support ribprojecting from the boundary in engagement with the delivery tube. Thesupport rib can include a pair of support rib portions. The deliverytube assembly can include a pair of end fittings to receive aperistaltic tube, and the support rib can be substantially alignedbetween the pair of end fittings. Additional features of the cassette asdisclosed herein can be combined with the support rib of this aspect.

According to another aspect of the disclosed subject matter, a devicefor delivering a beneficial agent is provided. The device generallyincludes a pump and a cassette. The pump includes a pump housingcontaining a pump assembly having a fluid drive component. The pumphousing has a receiving region disposed proximate the fluid drivecomponent. The cassette can include any combination of featuresdescribed herein.

According to another aspect of the disclosed subject matter, and furtherto the above, a device for delivering a beneficial agent is provided.The device generally includes a cassette, a pump, a delivery tube and alock member. The cassette includes a cassette housing with a fluidreservoir defined therein. The cassette housing has a cassette baseregion. The delivery tube is fluidly coupled with the fluid reservoir.The pump includes a pump housing containing a pump assembly having afluid drive component. The pump housing has a receiving region toreceive the cassette base region. The fluid drive component is disposedproximate the receiving region. The lock member is coupled to the pumphousing and is movable between an open position and a closed position.The cassette is capable of being inserted into and removed from thereceiving region when the lock member is in the open position. Thecassette is secured to the pump with the cassette base region within thereceiving region and a length of the delivery tube in operativeengagement with the fluid drive component when the lock member is in theclosed position.

Additionally, and as embodied herein, an alignment pin can beoperatively coupled to the lock member. Movement of the lock memberbetween the open position and the closed position can extend at least aportion of the alignment pin into engagement with the cassette housing.The cassette housing can define a receiving recess proximate thecassette base region to receive the alignment pin when the lock memberis moved toward the closed position. The receiving recess can be taperedtoward a closed end. The receiving recess can be defined by an alignmentprojection projecting from the cassette body region into the cassettebase region. For example, the cassette base region can include analignment key having a receiving recess to receive the alignment pin.The alignment pin can include a tapered end. The lock member can includea protrusion, and the alignment pin can include a notch to receive theprotrusion to engage the lock member to operatively couple the alignmentpin to the lock member.

Furthermore, and as embodied herein, the lock member can include alatch, which can be configured as a cam lever. The receiving region canfurther include a torsion spring mechanically coupled to the latch tobias the latch toward the open position.

In addition, and as embodied herein, the latch can further include alatch cam surface, and the pump can further include an occlusion blockdisposed proximate the receiving region and having an occlusion blockcam surface. The occlusion block can be biased to urge the occlusionblock cam surface against the latch cam surface. The latch cam surfaceand the occlusion block cam surface can be configured to urge theocclusion block toward an operative position to hold the peristaltictube in functional relationship to the fluid drive component when thelatch is moved from the open position toward the closed position. Thelatch cam surface and the occlusion block cam surface can be configuredto define a dead zone where the occlusion block remains in the operativeposition during continued movement of the latch continues from the openposition to the closed position. For example, the dead zone can bedefined by 10 degrees of final movement of the latch from the openposition to the closed position with no corresponding movement of theocclusion block. The latch can include a pivotal latch mounted on ahinge. Alternatively, the latch can include a draw latch mounted forsliding movement.

According to another aspect of the disclosed subject matter, and furtherto the above, a device for delivering a beneficial agent is provided.The device generally includes a cassette, a pump, a delivery tube and alock member. The cassette includes a cassette housing with a fluidreservoir defined therein. The cassette housing has a cassette baseregion, and the cassette base region includes a radio frequencyidentification (RFID) shell housing a RFID tag. The delivery tube isfluidly coupled with the fluid reservoir. The pump includes a pumphousing containing a RFID reader and a pump assembly having a fluiddrive component. The pump housing has a receiving region to receive thecassette base region. The RFID reader and the fluid drive component aredisposed proximate the receiving region. The lock member is coupled tothe pump housing and is movable between an open position and a closedposition. The cassette is capable of being inserted into and removedfrom the receiving region when the lock member is in the open position.The cassette is secured to the pump with the cassette base region withinthe receiving region with the RFID tag disposed proximate the RFIDreader and a length of the delivery tube in operative engagement withthe fluid drive component when the lock member is in the closedposition.

Additionally, and as embodied herein, the RFID shell can include araised surface relative an adjacent surface of the cassette base region.The raised surface can have a height of about 2 mm relative the adjacentsurface. The receiving region can include a dimple having a bottomradius of 2.5 mm and a top radius of 6.25 mm, each as measured from anexterior of the pump housing. The RFID tag can be molded in the RFIDshell. Additionally or alternatively, the RFID tag can be bonded to theRFID shell. The RFID tag can include identification information for thecassette encoded thereon. The RFID tag can include attribute informationof a beneficial agent contained in the fluid reservoir encoded thereon.The attribute information can include one or more of a concentration, aformation date, and an expiration date of the beneficial agent.

Furthermore, and as embodied herein, the receiving region can furtherinclude a RFID receiving region with the RFID reader housed therein. TheRFID receiving region can be configured to engage the RFID shell whenthe cassette is secured to the pump with the cassette base region withinthe receiving region of the pump housing. The RFID receiving region canhave a shape configured to mate with the RFID shell. For example, theRFID shell can include a raised surface relative an adjacent surface ofthe cassette base region, and the RFID receiving region can include adimple configured to receive the raised surface when the cassette issecured to the pump with the cassette base region within the receivingregion of the pump housing. The RFID shell and RFID receiving region canbe configured to dispose the RFID tag within about 5 mm of the RFIDreader when the cassette is secured to the pump with the cassette baseregion within the receiving region of the pump housing. The RFID readercan have a range of detection configured to read the RFID tag only whenthe RFID receiving region is in engagement with the RFID shell. Thedevice can further include a processor coupled to the RFID reader andconfigured to verify identification information for the cassette encodedon the RFID tag. Additionally or alternatively, the processor can becoupled to the RFID reader and configured to enable operation of thepump if an expiration date of the beneficial agent encoded on the RFIDtag is not exceeded. In addition or as a further alternative, theprocessor can be coupled to the RFID reader and configured to determineone or more dosing options based at least in part on a concentration ofthe beneficial agent encoded on the RFID tag. The RFID tag can includehigh or ultra-high radio frequency ID.

According to another aspect of the disclosed subject matter, and furtherto the above, a drug delivery reservoir cassette for a pump having anRFID reader, a receiving region configured to receive the cassette, anda lock member movable between an open position and a closed position isprovided. The cassette includes a cassette housing with a fluidreservoir defined therein. The cassette housing has a cassette baseregion. The cassette base region includes a radio frequencyidentification (RFID) shell housing a RFID tag configured to be read bythe RFID reader. The cassette is capable of being inserted into andremoved from the receiving region when the lock member is in the openposition, and the cassette is secured to the pump with the cassette baseregion within the receiving region with the RFID tag disposed proximatethe RFID reader when the lock member is in the closed position.

The cassette can include any combination of features described herein.For example, and as embodied herein, the RFID shell comprises a raisedsurface relative an adjacent surface of the cassette base region theRFID shell can include a raised surface relative an adjacent surface ofthe cassette base region. The raised surface can have a height of about2 mm relative the adjacent surface. The receiving region can include adimple having a bottom radius of 2.5 mm and a top radius of 6.25 mm,each as measured from an exterior of the pump housing. The RFID tag canbe molded in the RFID shell. Additionally or alternatively, the RFID tagcan be bonded to the RFID shell. The RFID tag can include identificationinformation for the cassette encoded thereon. The RFID tag can includeattribute information of a beneficial agent contained in the fluidreservoir encoded thereon. The attribute information can include one ormore of a concentration, a formation date, and an expiration date of thebeneficial agent.

As embodied herein, any of the various devices and cassette can includea beneficial agent contained in the fluid reservoir. The beneficialagent can include one or more of levodopa and carbidopa.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and are intended toprovide further explanation of the disclosed subject matter claimed.

The accompanying drawings, which are incorporated in and constitute partof this specification, are included to illustrate and provide a furtherunderstanding of the disclosed subject matter. Together with thedescription, the drawings serve to explain the principles of thedisclosed subject matter.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an exploded perspective view of an exemplary device fordelivering a beneficial agent according to the disclosed subject matter.

FIG. 2 is a perspective view of the device of FIG. 1, with the cassettereceived by the pump and the lock member in an open position.

FIG. 3 is a perspective view of the device of FIG. 2, with the lockmember in a closed position.

FIGS. 4A-4G are perspective, front, rear, left side, right side, top andbottom views, respectively, of an exemplary cassette of the device ofFIG. 1.

FIGS. 5A-5G are perspective, front, rear, left side, right side, top andbottom views, respectively, of an exemplary pump of the device of FIG.1.

FIG. 6 is an exploded perspective view of an exemplary embodiment of apump assembly in accordance with the disclosed subject matter.

FIG. 7A a bottom view of an exemplary lock member of the pump of FIG. 1.

FIG. 7B is a cross-sectional view of the exemplary lock member takenalong line B-B of FIG. 7A.

FIG. 7C is a detailed view of region 7C of the cross section of theexemplary lock member of FIG. 7B.

FIG. 7D is a cross-sectional view of the exemplary lock member takenalong line D-D of FIG. 7A.

FIG. 7E is a partial rear view of the exemplary lock member of FIG. 7A.

FIG. 7F is a top view of the exemplary lock member of FIG. 7A.

FIG. 7G is a bottom perspective view of the exemplary lock member ofFIG. 7A.

FIG. 8A is a cross-sectional view of the exemplary device taken alongline 8A-8A of FIG. 2.

FIG. 8B is a cross-sectional view of the exemplary device taken alongline 8B-8B of FIG. 3.

FIG. 9A is a cross-sectional view of the exemplary device taken alongline 9A-9A of FIG. 2.

FIG. 9B is a cross-sectional view of the exemplary device of FIG. 9A,with the lock member urged from the open position toward the closedposition.

FIG. 9C is a cross-sectional view of the exemplary device of FIG. 9A,with the lock member urged further from the open position toward theclosed position.

FIG. 9D is a cross-sectional view of the exemplary device taken alongline 9D-9D of FIG. 3, with the lock member fully engaged.

FIG. 10 is a cross-sectional view of the exemplary device taken alongline 10-10 of FIG. 3.

FIG. 11A is an enlarged perspective view of an alternative embodiment ofa membrane for a pump housing in accordance with the disclosed subjectmatter.

FIG. 11B is an enlarged perspective view of another alternativeembodiment of a membrane for a pump housing in accordance with thedisclosed subject matter.

FIG. 11C is an enlarged perspective view of yet another alternativeembodiment of a membrane for a pump housing in accordance with thedisclosed subject matter.

FIG. 12A is a top perspective view of an exemplary battery cover door ofthe pump of FIG. 1, with the battery cover door in a closed position,and selected portions cut away for purpose of illustration.

FIG. 12B is a top view of the exemplary battery cover door of FIG. 12A,with the battery cover door in an open position, and selected portionscut away for purpose of illustration.

FIG. 13 is a plan view of an exemplary delivery tube assembly and fluidreservoir for use with the disclosed subject matter.

DESCRIPTION

Reference will now be made in detail to the various exemplaryembodiments of the disclosed subject matter, exemplary embodiments ofwhich are illustrated in the accompanying drawings. The structure andcorresponding method of operation of and method of using the disclosedsubject matter will be described in conjunction with the detaileddescription of the system.

The apparatus and methods presented herein can be used for administeringany of a variety of suitable therapeutic agents or substances, such as adrug or biologic agent, to a patient. For example, and as embodiedherein, the device can include a pump joined to a cassette, which caninclude a fluid reservoir containing a fluid substance and can be joinedto a delivery tube system. In operation, the pump can operate on thecassette to deliver the fluid substance through the tubing system. Inthis manner, the device is capable of administering a dosage of thefluid substance, such as a therapeutic agent, including a formulation ina liquid or gel form, through the delivery tube system and to a patient.In some embodiments, the fluid therapeutic agent can include one or morepharmaceutical or biologic agents. For example and without limitation,one such fluid therapeutic agent can be a central nervous system agent,such as levodopa. The central nervous system agent can be administeredalone or in combination with, for example and without limitation, adecarboxylase inhibitor, such as carbidopa.

In accordance with one aspect of the disclosed subject matter, a drugdelivery reservoir cassette for a pump is provided. The pump has a lockmember movable between an open position and a closed position, such asdescribed further below. The cassette generally includes a cassettehousing including a cassette body region and a cassette base region. Thecassette housing has a front surface, a back surface and lateralsidewalls. The cassette housing defines a transverse axis extendingbetween the lateral sidewalls and a longitudinal axis perpendicular tothe transverse axis. The cassette body region defines a fluid reservoirchamber therein. As embodied herein, for purpose of illustration and notlimitation, the cassette base region can be disposed along thelongitudinal axis from the cassette body region. The cassette baseregion has a boundary configured to be received by the pump. Thecassette base region can include one or more features as describedherein for alignment and securement of the cassette when received by thepump.

As embodied herein, the boundary can include a pair of opposing railsdisposed on opposite sides of the longitudinal axis. For example, thepair of opposing rails can be substantially symmetrical about thelongitudinal axis. Each of the opposing rails can be recessed relativean adjacent portion of the boundary. The pair of opposing rails can bealigned along a transverse axis relative the longitudinal axis. Each ofopposing rails can define an abutment surface generally parallel withthe transverse axis.

Additionally or alternatively, or in combination with any of thefeatures of the cassette base region described herein, the cassette baseregion can include an engagement surface configured to be engaged by thelock member when in the closed position. For example, the pair of railscan be spaced from the engagement surface in a direction along thelongitudinal axis, if combined together. As embodied herein, theengagement surface can be substantially coplanar with the back surfaceof the cassette housing. Alternatively, the engagement surface caninclude a recessed area recessed relative the back surface of thecassette base region. The recessed area can be shaped to receive thelock member when in the closed position. As embodied herein, therecessed area can taper to a reduced or smaller dimension in plan viewtoward an end of the cassette housing.

Additionally or alternatively, or in combination with any of thefeatures of the cassette base region described herein, the boundary caninclude an alignment key aligned parallel with the longitudinal axis anddefining a receiving recess to receive an alignment pin from the pump.As embodied herein, the alignment key can be centered between thelateral side walls. The alignment key can project into the boundary. Thealignment key can project from the cassette body region into thecassette base region. The alignment key can be channel-shaped.Additionally or alternatively, the receiving recess can be tapered alongthe longitudinal axis.

Additionally or alternatively, or in combination with any of thefeatures of the cassette base region described herein, the cassette caninclude a delivery tube assembly extending from the fluid reservoirchamber, and the cassette base region can include a support ribprojecting from the boundary in engagement with the delivery tube. Asembodied herein, the support rib can include a pair of support ribportions. The delivery tube assembly can include a pair of end fittingsto receive a peristaltic tube, and the support rib can be substantiallyaligned between the pair of end fittings.

Additionally or alternatively, or in combination with any of thefeatures of the cassette base region described herein, the cassette baseregion can include a flat surface proximate an end of the cassettehousing. The flat surface can include two flat surface portions.

Additionally or alternatively, or in combination with any of thefeatures of the cassette base region described herein, the cassette baseregion can include a contoured surface configured to mate with acorresponding surface of the pump. The contoured surface can have aconcave shape directed toward the boundary in plan view. The contouredsurface can be substantially symmetrical about the longitudinal axis.

According to another aspect of the disclosed subject matter, and furtherto the above, a device for delivering a beneficial agent is provided.The device generally includes a pump and a cassette. The pump includes apump housing containing a pump assembly having a fluid drive component.The pump housing has a receiving region disposed proximate the fluiddrive component, the receiving region configured to receive at least aportion of the cassette. The cassette can include any combination offeatures of the cassette base region described herein.

The accompanying figures, where like reference numerals refer toidentical or functionally similar elements throughout the separateviews, serve to further illustrate various embodiments and to explainvarious principles and advantages all in accordance with the disclosedsubject matter. For purpose of explanation and illustration, and notlimitation, exemplary embodiments of the device for delivering abeneficial agent, including a drug delivery reservoir cassette, inaccordance with the disclosed subject matter are shown in FIGS. 1-13.

While the disclosed subject matter is described with respect to adelivery device to administer a dose of therapeutic agent, one skilledin the art will recognize that the disclosed subject matter is notlimited to the illustrative embodiment, and that the devices disclosedherein can be configured for delivering any suitable substancetherethrough. In addition, the components and the method of using thedelivery device are not limited to the illustrative embodimentsdescribed or depicted herein. For example, the delivery device embodiedherein can be used with other tubing assemblies and components thereoffor similar benefits and advantages, and are not limited for use withthe delivery tubing herein.

Referring to an illustrative embodiment of FIGS. 1-3, delivery device100 includes a cassette 10 including a cassette housing 11. Cassettehousing 11 can have a cassette body region 14. Cassette body region 14can define an interior to contain a fluid reservoir 12 (shown forexample in FIG. 13) within the cassette housing 11, as discussed furtherherein. Cassette body region 14 can be any suitable shape to accommodatea fluid reservoir 12. For example, and as embodied herein, cassette bodyregion 14 can have a bulbous shape defining a curved surface proximate aback surface of the cassette housing 11, which can accommodate a fluidreservoir 12 having a similar size and shape. As embodied herein,cassette body region 14 can have a generally flat surface proximatefront surface of cassette housing 11, opposite the back surface, whichcan allow cassette housing 11 to lay flat on a planar surface, such as atable, to facilitate a user to insert or remove cassette 10 fromengagement with a pump 30, as discussed herein.

Furthermore, and as embodied herein, the cassette housing 11 can have acassette base region 13 to join with the pump mechanism 30, as discussedfurther herein. As shown, for purpose of illustration and notlimitation, cassette base region 13 can be disposed along a longitudinalaxis, such as disposed along the longitudinal axis a from the cassettebody region 14 defined along cassette 10.

The delivery device 100 also includes a pump 30, which can include apump housing 31. With reference to FIGS. 1-3 and 5A-5G, the pump housing31 can include a receiving region 32 to receive the cassette base region13. For example, and as embodied herein, the receiving region can bedisposed at one end of the pump 30. Referring now to FIGS. 1-3, thecassette base region 13 can be inserted into the receiving region 32 andsecured to the pump 30 by closing lock member 40 into engagement withthe cassette 10. As embodied herein, for illustration and notlimitation, the lock member 40 is in the form of a lever, which closesover the cassette 10. In this manner, and as shown for example in FIGS.9A-9D, the lock member 40 can also be configured to engage and secureperistaltic tube 23 to the pumping mechanism 30, as discussed furtherherein. The cassette 10 can be inserted into and removed from thereceiving region 32 when the lock member 40 is in the open position.When the lock member 40 is in the closed position, the cassette 10 canbe secured to the pump 30 with the cassette base region 13 disposedwithin the receiving region 32 and inhibited or prevented fromdisengagement from the pump 30.

Additionally, with reference to FIGS. 5A-5B, pump housing 31 can includeone or more inputs and outputs for interaction with a user. For example,and as embodied herein, pump housing 31 can include input buttons 85disposed thereon, to provide, for example and without limitation, dosagesettings and other device settings. Input buttons 85 can be formed usingany suitable techniques. For example, and as embodied herein, inputbuttons 85 can be overmolded onto pump housing 31. Input buttons 85 canbe formed of a material having a coefficient of static friction greaterthan that of the remainder of the pump housing 31, such as and withoutlimitation, OM 3060-1 (GLS Corporation Versaflex®) and TM5ADT, TM6ADTand TM7ADT (each from Kraiburg TPE Corporation THERMOLAST®) which can,for example and without limitation, prevent sliding of pump housing 31when disposed face down on a planar surface, such as a table, tofacilitate a user to insert or remove cassette 10 from engagement with apump 30, as discussed herein. Pump housing 31 can also include an outputdisplay 86. Output display 86 can be any suitable display to providevisual information to a user, for example and without limitation, an LCDor LED display or any other suitable display.

Referring now to FIGS. 4A-4G and 5A-5G, for the purpose of illustrationand not limitation, the cassette 10 can be configured to be alignedand/or secured with the pump 30 via one or more features within thereceiving region 32. For example, and as embodied herein, cassette baseregion 13 can define a boundary 28 to be received by receiving region 32of the pump. As embodied herein, cassette base region 13 can include oneor more rails 29 (as shown for example in FIG. 4B) configured to receiveprotrusions 33 of receiving region 32. As shown for example in FIG. 4B,cassette base region 13 can include a pair of opposing rails 29, whichcan be disposed on opposite sides of a longitudinal axis a defined bycassette 10, and can be substantially symmetrical about the longitudinalaxis a. Additionally, and as embodied herein, each rail 29 can berecessed relative an adjacent portion of the boundary 28. As shown forpurpose of illustration, rails 29 can be aligned along a transverse axisb defined across cassette 10. As embodied herein, each rail 29 can thusdefine an abutment surface generally parallel with the transverse axisb.

Additionally, and as embodied herein, protrusions 33 to receive rails 29can be formed in pump base block 1 (as shown for example in FIG. 6). Forpurpose of illustration, and as embodied herein, pump housing 31 caninclude one or more slots 39 (as shown for example in FIGS. 11A-11C)configured to receive protrusions 33 of the pump base block 1.Alternatively, the configuration of the rails and protrusions can bereversed, such that rails 29 are disposed on the cassette 10 and slots39 are disposed on the pump 30.

Additionally or alternatively, and as embodied herein, the cassette 10can be secured and aligned via an engagement surface 17, which can bereceived and captured by lock member 40 when in the closed position, asdiscussed further herein. Engagement surface 17 can be substantiallycoplanar with the back surface of the cassette housing 11.Alternatively, engagement surface 17 can include a recessed area 92recessed relative the back surface of the cassette housing 17. Forpurpose of illustration, and as embodied herein, recessed area 92 can beshaped to receive and/or mate with at least a portion of lock member 40when in the closed position, as shown for example in FIGS. 2-3. As such,and as embodied herein, recessed area 92 can taper to a smaller crossdimension toward an end 82 of the cassette housing 11, as shown forexample in FIG. 4C. With reference to FIG. 4B, as embodied herein, theengagement surface 17 can be configured as an elongated strip ofmaterial to be engaged by lock member 40 when closed about engagementfeature 17. In this manner, engagement surface 17 can form a unitarybridge across the longitudinal axis a. Alternatively, engagement surface17 can include a pair of engagement surface portions on opposite sidesof the longitudinal axis a, and in some embodiments, the pair ofengagement surface portions can be substantially symmetrical about thelongitudinal axis a.

Additionally or alternatively, and as embodied herein, the cassette 10can be secured and aligned with the pump 30 via alignment pin 41 in thelocking mechanism. As such, and as embodied herein, cassette base region13 can include an alignment key 44 defining a receiving recess toreceive alignment pin 41. For purpose of illustration and notlimitation, and as embodied herein, alignment key 44 can be centeredbetween the lateral side walls of cassette housing 11. As embodiedherein, alignment key 44 can project into the boundary 28, and in someembodiments, alignment key 44 can project from the cassette body region14 into the cassette base region 13. Alignment key 44 can have anysuitable shape to receive alignment pin 41. For example and notlimitation, alignment key 44 can be cylindrical, channel-shaped or anyother suitable shape. Additionally or alternatively, as shown forexample in FIG. 8B, the receiving recess formed by alignment key 44 canbe tapered along the longitudinal axis a to assist with receipt andalignment of alignment pin 41 therein.

For purpose of illustration and not limitation, as shown for example inFIGS. 5C and 8A-8B, lock member 40 can be biased, such as by a torsionspring 42, to urge lock member 40 toward the open position.Additionally, and embodied herein, lock member 40 can include a pindriver 43, which can have a projection 43 a received in notch 41 a ofalignment pin 41. As embodied herein, pin driver 43 can be urged uponmovement of lock member 40 toward the open position to drive thealignment pin 41 away from retention feature 44 in the disposablecassette housing 11 (as shown for example in FIG. 8A). With reference toFIG. 8B, when the lock member 40 is moved to the closed position, thelock member 40 urges the pin driver 43 to drive the alignment pin 41into the retention feature 44 of the cassette housing 11. For purpose ofillustration and not limitation, as embodied herein, the alignment pin41 can be tapered. The material for the alignment pin 41 can bestainless steel.

Additionally or alternatively, as further embodied herein, cassette 10can include support rib 54 as shown in FIG. 4B. In this manner, and asembodied herein, pump 30 can include a tubing guide ridge 52 (as shownfor example in FIG. 5C), which can engage or restrict movement of theperistaltic tube 23 when the cassette 10 is received within thereceiving region 32. When the cassette 10 is received within thereceiving region 32, tubing guide ridge 52 can align with support rib 54(as shown for example in FIG. 4B) on the cassette base region 11, forexample and as embodied herein to guide peristaltic tube 23 intoengagement with an occlusion sensor. For purpose of illustration, and asembodied herein, support rib 54 can project from boundary 28.Additionally, and as embodied herein, support rib 54 can include a pairof support rib portions. Alternatively, support rib 54 can be configuredas a single, unitary rib. As shown in FIG. 4B, for purpose ofillustration and not limitation, cassette housing 11 can include a pairof end fittings 24 a, 24 b to support peristaltic tube 23, and ifprovided, support rib 54 can be substantially aligned with end fittings24 a, 24 b.

Additionally or alternatively, and as further embodied herein, cassettebase region 13 can include a contoured surface 80 configured to matewith a corresponding contoured end 81 of pump 30, as shown in FIG. 1.For purpose of illustration, and not limitation, contoured surface 80can include contoured end portions 80 a, 80 b having a concave contourrelative cassette base region 13 proximate opposing sides of cassettebase region 13. Additionally or alternatively, cassette base region 13can include a selected flat surface 82 proximate an end of cassettehousing 11. As embodied herein, flat surface 82 can include flat surfaceportion 82 a, 82 b proximate lateral side walls of cassette housing 11.Flat surface 82 of cassette base region 13 can be sized and shaped toengage corresponding flat surface 83 of receiving region 32 of pump 30.

These various features of the cassette base region can be combined invarious combinations and arrangements as desired. For example and notlimitation, the cassette can be provided with the rails and engagementsurface, without an alignment key if desired. Likewise, and withoutlimitation, the cassette can be provided with a pair of alignment keyseach offset from the longitudinal axis a.

According to another aspect of the disclosed subject matter, a devicefor delivering a beneficial agent is provided. The device generallyincludes a cassette, a pump, a delivery tube and a lock member. Thecassette includes a cassette housing with a fluid reservoir definedtherein. The cassette housing has a cassette base region. The deliverytube is fluidly coupled with the fluid reservoir. The pump includes apump housing containing a pump assembly having a fluid drive component.The pump housing has a receiving region to receive the cassette baseregion. The fluid drive component is disposed proximate the receivingregion. The lock member is coupled to the pump housing and is movablebetween an open position and a closed position. The cassette is capableof being inserted into and removed from the receiving region when thelock member is in the open position. The cassette is secured to the pumpwith the cassette base region within the receiving region and a lengthof the delivery tube in operative engagement with the fluid drivecomponent when the lock member is in the closed position.

Additionally, and as embodied herein, an alignment pin can beoperatively coupled to the lock member. Movement of the lock memberbetween the open position and the closed position can extend at least aportion of the alignment pin into engagement with the cassette housing.The cassette housing can define a receiving recess proximate thecassette base region to receive the alignment pin when the lock memberis moved toward the closed position. The receiving recess can be taperedtoward a closed end. For example, the receiving recess can be defined byan alignment projection, such as an alignment key, projecting from thecassette body region into the cassette base region. The alignment pincan include a tapered end. To move the alignment pin into an extendedposition, the lock member can include a protrusion, and the alignmentpin can include a notch to receive the protrusion to engage the lockmember to operatively couple the alignment pin to the lock member.Furthermore, and as embodied herein, the lock member can include alatch, and receiving region can further include a torsion springmechanically coupled to the lock member to urge the latch toward theopen position.

In addition, and as embodied herein, the latch can further include alatch cam surface, and the pump can further include an occlusion blockdisposed proximate the receiving region and having an occlusion blockcam surface. The occlusion block can be biased to urge the occlusionblock cam surface against the latch cam surface. The latch cam surfaceand the occlusion block cam surface thus can be configured to urge theocclusion block toward an operative position to hold the peristaltictube in functional relationship to the fluid drive component when thelatch is moved from the open position toward the closed position. Thelatch cam surface and the occlusion block cam surface can be configuredto define a dead zone where the occlusion block remains in the operativeposition during continued movement of the latch continues from the openposition to the closed position. The dead zone can be defined by 10degrees of final movement of the latch from the open position to theclosed position. The latch comprises a pivotal latch mounted on a hinge.Alternatively, the latch can include a draw latch mounted for slidingmovement. The features of this aspect can be combined with one or morefeature of the apparatus and methods set forth above.

With reference to FIG. 6, the pump housing 31 can include a pumpassembly 200 having a fluid drive component. The pump assembly 200 canbe configured, for example, as a peristaltic pump. For example, aperistaltic pump can include a motor 3, a cam shaft 2, and a pluralityof finger plates 34 disposed along the length of the cam shaft 2. Thecam shaft 2 is coupled to the motor 3 for rotation about a longitudinalaxis a of the cam shaft 2, and has at least one radially-outwardprojection 5 defining a helical engagement portion disposed along alength of the cam shaft 2. The plurality of finger plates 34 aredisposed along the length of the cam shaft 2. Each finger plate 34 ismounted for movement in a transverse direction relative to thelongitudinal axis a of the cam shaft 2, and has an aperture definedtherein to receive the cam shaft 2 therethrough. Additional details ofsuitable fluid drive components and related features of the pumpsuitable for use herewith are described in concurrently filedapplications by Applicant, each entitled “PUMP, MOTOR AND ASSEMBLY FORBENEFICIAL AGENT DELIVERY,” Ser. Nos. ______, ______ and ______, each ofwhich is incorporated by reference in its entirety.

For purpose of illustration and not limitation, as embodied herein, lockmember 40 can be configured as a latch or cam lever, such as a pivotallatch, a draw latch, or any other suitable latching mechanism. As shownfor example in FIGS. 6 and 7A-7G, lock member 40 can be configured as apivotal latch. Lock member 40 can include a latch cam surface 48 toengage an occlusion block, as discussed further herein. Additionally,and as embodied herein, lock member 40 can include a hinge receptacle 75to receive a hinge pin 45 to allow pivotal movement of lock member 40.As embodied herein, hinge pin 45 can also engage pin driver 43 to lockmember 40 to allow pivotal movement of pin driver 43 with lock member40, as discussed further herein. Additionally, lock member 40 can bebiased toward an open position, such as by torsion spring 42.Furthermore, and as embodied herein, lock member 40 can include aclosure sensor receptacle 55 to receive a closure sensor, such as forpurpose of illustration and not limitation, as embodied herein, a magnetto trigger a reed sensor, as discussed further herein. As shown in FIG.7A, and as embodied herein, lock member 40 includes a tapered end 76sized and shaped to engage a corresponding recess in cassette baseregion 13, as discussed further herein. As shown in FIG. 7F, for purposeof illustration and not limitation, lock member 40 can include one ormore raised surface features 79 to assist with engagement of lock member40, for example by a user, to move lock member 40 between the openposition and closed position.

Referring now to FIGS. 9A-9D, when the lock member 40 is moved into theclosed position, the lock member 40, urged by torsion spring 42, pivotsabout the lever hinge 45. Tension springs 46 urge the occlusion blockcam surface 47 of occlusion block 9 against the latch cam surface 48 oflock member 40. As such, and with reference to FIGS. 9A-9D, theocclusion block 9 can be positioned, by the stroke of the lock member40, an appropriate distance to dispose the peristaltic tube 23operatively against the peristaltic fingers 34 when closed, as shown forexample in FIG. 9D.

As illustrated for example in FIG. 9C, with the lock member 40 within acertain angle of rotation α, for example and without limitation, withina range of approximately 0°-10° relative to the pump 30, the lock memberlever cam surface 48 as embodied herein enters a so-called “dead zone.”That is, within the “dead zone,” the lock member 40 can continue to beclosed and latch against the pump housing 31, while the occlusion block9 remains positioned in a fully latched state. In this manner, theocclusion block 9 is properly positioned relative to the peristalticfingers 34 even if the lock member 40 is not fully closed, and thus theeffect of mechanical tolerances in the locking assembly on the positionof the occlusion block 9 can be reduced. A closure indicator, embodiedherein as a magnet disposed in closure sensor receptacle 55 of lockmember 40, or other suitable closure elements, can be detected by aclosure sensor, embodied herein as a magnetic field detector disposed inthe pump housing 31 proximate the lock member 40 to allow the pumpassembly to detect when the lock member 40 is fully closed.

As illustrated for example in FIG. 9D, with lock member 40 further urgedinto the closed position, distal projection 72 of lock member 40 movesalong cam surface of lock member release 70 to urge lock member release70 away from lock member 40 and allow distal projection 72 to movebeyond and engage corresponding projection 73 of release 70. In thismanner, lock member 40 is secured in the closed position by projection73 of release 70, which is biased into engagement with lock member 40 byspring 74. To release lock member 40, lock member release 70 can beurged away from lock member 40 to move projection 73 out of alignmentwith distal projection 72 to allow lock member 40, which as describedherein can be biased in the open position, to be urged into the openposition, as embodied herein by torsion spring 42.

As illustrated for example in FIG. 6, in some embodiments, set screws 49can be provided to the lever hinge pin 45 to allow for adjustment duringassembly to account for mechanical tolerances and provide a suitableocclusion distance. Polishing the surface of lock member 40 can reducefriction between the occlusion block surface 47 and the lock member 40.The roughness average of the cam lever can be about 0.4 μm. This can beaccomplished by one or more of tumbling, anodizing, and polishing thelock member 40. Additionally, providing an occlusion block cam surface47 with a slope of 30 degrees can increase the vertical component of theforce of the lock member 40.

According to another aspect of the disclosed subject matter, and furtherto the above a device for delivering a beneficial agent is provided. Thedevice generally includes a cassette, a pump, a delivery tube and a lockmember. The cassette includes a cassette housing with a fluid reservoirdefined therein. The cassette housing has a cassette base region, andthe cassette base region includes a radio frequency identification(RFID) shell housing a RFID tag. The delivery tube is fluidly coupledwith the fluid reservoir. The pump includes a pump housing containing aRFID reader and a pump assembly having a fluid drive component. The pumphousing has a receiving region to receive the cassette base region. TheRFID reader and the fluid drive component are disposed proximate thereceiving region. The lock member is coupled to the pump housing and ismovable between an open position and a closed position. The cassette iscapable of being inserted into and removed from the receiving regionwhen the lock member is in the open position. The cassette is secured tothe pump with the cassette base region within the receiving region withthe RFID tag disposed proximate the RFID reader and a length of thedelivery tube in operative engagement with the fluid drive componentwhen the lock member is in the closed position.

Additionally, and as embodied herein, the RFID shell can include araised surface relative an adjacent surface of the cassette base region.The raised surface can have a height of about 2 mm relative the adjacentsurface. The receiving region can include a dimple having a bottomradius of 2.5 mm and a top radius of 6.25 mm, each as measured from anexterior of the pump housing. The RFID tag can be molded in the RFIDshell. Additionally or alternatively, the RFID tag can be bonded to theRFID shell. The RFID tag can include identification information for thecassette encoded thereon. The RFID tag can include attribute informationof a beneficial agent contained in the fluid reservoir encoded thereon.The attribute information can include one or more of a concentration, aformation date, and an expiration date of the beneficial agent.

Furthermore, and as embodied herein, the receiving region can furtherinclude a RFID receiving region with the RFID reader housed therein. TheRFID receiving region can be configured to engage the RFID shell whenthe cassette is secured to the pump with the cassette base region withinthe receiving region of the pump housing. The RFID receiving region canhave a shape configured to mate with the RFID shell. For example, theRFID shell can include a raised surface relative an adjacent surface ofthe cassette base region, and the RFID receiving region can include adimple configured to receive the raised surface when the cassette issecured to the pump with the cassette base region within the receivingregion of the pump housing. The RFID shell and RFID receiving region canbe configured to dispose the RFID tag within about 5 mm of the RFIDreader when the cassette is secured to the pump with the cassette baseregion within the receiving region of the pump housing. The RFID readercan have a range of detection configured to read the RFID tag only whenthe RFID receiving region is in engagement with the RFID shell. Thedevice can further include a processor coupled to the RFID reader andconfigured to verify identification information for the cassette encodedon the RFID tag. Additionally or alternatively, the processor can becoupled to the RFID reader and configured to enable operation of thepump if an expiration date of the beneficial agent encoded on the RFIDtag is not exceeded. In addition or as a further alternative, theprocessor can be coupled to the RFID reader and configured to determineone or more dosing options based at least in part on a concentration ofthe beneficial agent encoded on the RFID tag. The RFID tag can includehigh or ultra-high radio frequency ID.

According to another aspect of the disclosed subject matter, and furtherto the above, a drug delivery reservoir cassette for a pump having anRFID reader, a receiving region configured to receive the cassette, anda lock member movable between an open position and a closed position isprovided. The cassette includes a cassette housing with a fluidreservoir defined therein. The cassette housing has a cassette baseregion. The cassette base region includes a radio frequencyidentification (RFID) shell housing a RFID tag configured to be read bythe RFID reader. The cassette is capable of being inserted into andremoved from the receiving region when the lock member is in the openposition, and the cassette is secured to the pump with the cassette baseregion within the receiving region with the RFID tag disposed proximatethe RFID reader when the lock member is in the closed position.

The cassette can include any combination of features described herein.For example, and as embodied herein, the RFID shell comprises a raisedsurface relative an adjacent surface of the cassette base region. theRFID shell can include a raised surface relative an adjacent surface ofthe cassette base region. The raised surface can have a height of about2 mm relative the adjacent surface. The receiving region can include adimple having a bottom radius of 2.5 mm and a top radius of 6.25 mm,each as measured from an exterior of the pump housing. The RFID tag canbe molded in the RFID shell. Additionally or alternatively, the RFID tagcan be bonded to the RFID shell. The RFID tag can include identificationinformation for the cassette encoded thereon. The RFID tag can includeattribute information of a beneficial agent contained in the fluidreservoir encoded thereon. The attribute information can include one ormore of a concentration, a formation date, and an expiration date of thebeneficial agent. The features of these aspects can be combined with oneor more features of the apparatus and methods set forth above.

For example and as embodied herein, cassette 10 can include an RFIDenclosure shell to house an RFID tag. RFID enclosure shell can beconfigured to engage RFID tag with a corresponding RFID reader in pump30. With reference to FIGS. 4B and 10, for purpose of illustration andnot limitation, the RFID enclosure shell 19 can be shaped as a raisedsurface projecting into cassette base region 13. As shown for example inFIG. 10, RFID tag 18 be disposed within RFID enclosure shell 19 by anysuitable technique. For example and without limitation, RFID tag 18 canbe injection molded into the RFID enclosure shell 19. Alternatively, theRFID tag 18 can bonded to the RFID enclosure shell 19, for example by apotting technique, such as epoxy potting.

Referring now to FIGS. 5C and 10, as embodied herein, the pump housing31 can have a RFID receiving region 38 to house an RFID reader 37 andcan engage with the RFID enclosure shell 19 of the cassette housing 11.The RFID receiving region 38 can be configured as a dimple disposed inthe receiving region 32 of the pump housing 31. For example, and asembodied herein, the dimple can be 1.9 mm deep, and can include a 2.5 mmbottom radius and a 6.25 mm top radius measured from the exterior of thepump housing 31. The RFID enclosure shell 19 and the RFID receivingregion 38 can be configured to allow the RFID tag 18 to be disposedwithin 5 mm of an RFID reader 37 when the cassette housing 11 and thepump housing 31 are joined together, as described in further detailbelow. For purpose of illustration, and not limitation, as embodiedherein, RFID reader 37 can be embedded in a circuit board disposed inpump housing 31. RFID reader 37 can be “box-shaped,” such as a square orrectangular spiral, and formed by a number of wire windings, embodiedherein as 14 coil windings, with 7 windings in each of two layers of thePCB. As such, RFID reader 37 can have outer cross-dimensions of0.360″×0.372″ and can have a central aperture having innercross-dimensions of 0.204″×0.228″. In this manner, RFID reader 37 can beconfigured with a range of detection to only detect RFID tag 18 when thecassette housing 11 is joined to the pump housing 31, such that anotherRFID tag further away from the RFID reader 37 would be outside the rangeof detection. Additionally or alternatively, the RFID reader 37 can beconfigured to determine which one of a plurality of RFID tags is closerto the RFID reader 37, and thus can determine which one of a pluralityof cassette housings is joined to the pump housing 31. RFID reader 37can utilize any suitable RFID techniques, including and withoutlimitation, low, high, or ultra-high radio frequency ID.

RFID reader 37 also can be configured to identify drug cassettes andread information encoded in RFID tag 18. In this manner, the system canbe used to detect cassettes that are not compatible or warrantied foruse with the pump or otherwise to deter counterfeiting of drugcassettes. For purpose of illustration and not limitation, RFID tag 18can include identification information for cassette 10 encoded thereon.Additionally or alternatively, RFID tag 18 can include attributeinformation of a beneficial agent contained in the fluid reservoirencoded thereon, which can include, without limitation, a concentration,a formation date, and/or an expiration date of the beneficial agent.RFID reader 37 can be coupled to a processor, which can be configured toreceive and verify the identification information for cassette 10encoded on the RFID tag, and can be further configured to enableoperation of pump 30 only if the identification information for cassette10 can be verified. Additionally or alternatively, the processor can beconfigured to enable operation of pump 30 only if an expiration date ofthe beneficial agent, if encoded on the RFID tag 18, is not exceeded.Additionally or as a further alternative, processor coupled to RFIDreader 37 can be configured to determine one or more dosing optionsbased at least in part on a concentration of the beneficial agentcontained within cassette 10, if encoded on the RFID tag 18.

The housing provided herein can be made of a variety of constructionsand configurations. For example, and not limitation, with reference toFIGS. 1-3 and 5C, the pump housing 31 can include a rear closure portion35 and a front closure portion 36. One of the closure portions, such asthe rear closure portion 35 as embodied herein, can include a membrane37 disposed between the receiving region 32 and the fluid drivecomponent, as embodied herein, to cover the finger plates of theperistaltic pump. In such a configuration, the finger plates of theperistaltic pump will push on the peristaltic tube 23 with the membrane37 disposed in-between the fingers and the peristaltic tube 23. Themembrane 37 can prevent debris and fluid from contacting and interferingwith the pumping mechanism. The membrane 37 can be a thermoformed orinjection molded membrane, which can be over-molded onto the rearclosure portion 35. As embodied herein, the membrane 37 can define arectangular-shaped protrusion extending from an end of the rear closureportion 35. Membrane 37 can define vertical sides extending from therear closure portion 35 and forming slightly rounded corners at an outerface of the membrane 37. Additionally or alternatively, membrane 37 canhave a first side extending from the rear closure portion 35 to theouter face of the membrane 37 at a gradual slope, and can have anopposing side extending vertically from the rear closure portion 35 andforming rounded corners proximate the outer face of the membrane 37. Inthis manner, the gradual slope formed proximate the inlet side of theperistaltic tube 23 can allow for a more gradual compression of theperistaltic tube 23.

Furthermore, and as embodied herein, the membrane 37 can be formedhaving dimensions and using materials to reduce rigidity, and thusutilize less force from the pump to move the membrane 37 and engage theperistaltic tube 23. For example, increased thickness of the membrane 37can cause increased force applied by the pump during operation, andthus, increased power utilized and decreased battery performance. Assuch, the membrane 37 can have a thickness between 0.009 inches and0.019 inches, and in some embodiments can have a thickness between 0.009inches and 0.015 inches, which can provide suitable protection fromdebris and fluid ingress with suitable battery consumption. The materialproperties of the membrane 37, including flexibility, can similarlyaffect battery performance. In some embodiments, the membrane can beformed from Elastollan C80A, Estane 2103-90A, Elastollan S85A,Elastollan S95A or other suitable materials.

Referring now to FIGS. 11A-11C, alternative embodiments of a membrane 37are illustrated. As shown for example in FIG. 11A, membrane 37 a caninclude rounded corners on each end of membrane 37 a, and each roundedcorner can be tapered inward toward a center of membrane 37 a.Alternatively, as shown for example in FIG. 11B, membrane 37 b caninclude rounded corners on each end of membrane 37 b, and each roundedcorner can be tapered outward away from a center of membrane 37 b. As afurther alternative, as shown for example in FIG. 11C, membrane 37 c caninclude rounded corners on each end of membrane 37 c, one of the roundedcorners being tapered inward toward a center of membrane 37 c and one ofthe rounded corners being tapered outward away from a center of membrane37 c. In each configuration, the curvature formed proximate the inletside and outlet side of the peristaltic tube 23 can allow forperistaltic tube 23 to expand more easily after compression. For exampleand without limitation, as embodied herein, the curvature proximate theinlet side can reduce or prevent contact with one or more end fittingsor joints proximate inlet side of peristaltic tube 23. Additionally oralternatively, the curvature formed proximate the outlet side canprevent or inhibit the membrane from being urged away from the occlusionsensor. Membrane 37, 37 a, 37 b and 37 c can be formed having anysuitable thickness to prevent debris or liquid from entering pumphousing 31 and to avoid interference with peristaltic tube 23 and/orengagement of finger plates 4 therewith. For purpose of illustration andnot limitation, as embodied herein, membrane 37, 37 a, 37 b and 37 c canhave a thickness of 0.33 mm.

Referring now to FIGS. 12A-12B, for the purpose of illustration and notlimitation, in some embodiments, the pump housing 31 can include abattery cover 611. The battery cover 61 can have a rectangular shapedefining a length and width. In some embodiments, the battery cover 61can be hingedly connected to the pump housing 31 along the width(referred to as a “barn door arrangement”). In alternative embodimentsbattery cover 61 can be hingedly connected to the pump housing 31 alongthe length (referred to as a “tailgate arrangement”). FIGS. 12A-12B showthe battery cover 61 in the barn door arrangement. As embodied herein,the pump housing 31 can include a rod 63. The battery cover 61 caninclude a hinge 62 having a ‘C’ shape. The C-shaped hinge 62 can allowthe battery cover 61 to snap off of the pump housing 31 if urged too faraway from the pump housing 31 without damaging the hinge and allowingthe battery cover 61 to be reinstalled. In this manner, preventingdamage to the battery cover 61 from over extension of the battery covercan provide a benefit for a user with poor dexterity. Battery cover 61can include a release button 64 coupled to a latch projection 65.Actuation of release button 64, for example by sliding release buttonaway from latch projection 65, can release latch projection from a latchreceptacle 66 in pump housing 31 to allow hinged movement of batterycover 61 away from pump housing 31. The battery compartment can alsoinclude a gasket to insulate the battery compartment and protect thebattery compartment from fluid ingress.

Referring now to FIG. 13, as embodied herein, cassette housing 11 cancontain a fluid reservoir therein. For example, the housing itself candefine the fluid reservoir, or an additional component to define thereservoir can be contained therein. If provided separately, the fluidreservoir 12 can be disposed in the cassette housing 11. For example,and as embodied herein, the cassette housing 11 can be configured withtwo enclosure clamshell portions 17 and 18 (as shown for example inFIGS. 1-3), which can receive and contain the fluid reservoir 12. Thetwo clamshell portions 17 and 18 can be adhered or otherwise joinedtogether, for example by ultrasonic welding.

As embodied herein, fluid reservoir 12 can include a flexible pouch,which can have any of a variety of suitable shapes. Opposing sides ofthe pouch can be secured about a perimeter to form the fluid reservoir12, for example by thermal or radio frequency (RF) welding or the like.The fluid reservoir 12 can have a dip tube 14. The dip tube 14 can beconfigured, for example and without limitation, from SUNLITE VYSUN102-80-26 (Non-DEHP PVC), DuPont Elvax 3182-2 EVA, or any suitabletubing material. As embodied herein, the dip tube 14 can have a lengthwithin a range of approximately 108-111 mm, with a plurality ofapproximately 2 mm diameter apertures disposed therein. The dip tube 14can extend from the fluid reservoir 12 to serve as a delivery tube ifdesired or appropriate. Alternatively, and as embodied herein, anadaptor disposed external to the cassette housing 11 can be provided andcoupled to a proximal end of the dip tube 14. In this manner, a separatedelivery tube can be coupled to the adaptor for delivery of thebeneficial agent from the fluid reservoir 12 to the user by operation ofthe pump 30. Additionally, a peristaltic tube can be provided between oras a part of the dip tube 14 and/or the delivery tube for interactionwith the pump 30.

For the purpose of illustration and not limitation, an exemplaryembodiment of such an adaptor is depicted in FIG. 13. As shown, thefluid reservoir 12 includes an adaptor 15 disposed external to thecassette housing 11. Adaptor 15 can be coupled to a proximal end of thedip tube 14. As embodied herein, a polypropylene-barbed elbow fitting 16is provided at the proximal end of the dip tube 14. The elbow fitting 16can be adhered to the exterior end of the dip tube 14 and oriented inplane with the fluid reservoir 12. A peristaltic tube 23 can beinstalled or coupled to an opposing end of the elbow fitting 16. Forexample, and as embodied herein, the peristaltic tube 23 can be formedfrom a section of Saint Gobain Biosil Precision tubing material. Theperistaltic tube 23 can have an inside diameter of 1.6 mm and an outsidediameter of 4.8 mm. A junction fitting 24 is joined to the peristaltictube 23, and a delivery tube 20 can be adhered into the junction fitting24. As such, the delivery tube 20 can be fluidly coupled with the fluidreservoir 12.

Each of the components described herein can be made of any suitablematerial (e.g., plastic, composites, metal, etc.) and technique for itsintended purpose. In addition to the specific embodiments claimed below,the disclosed subject matter is also directed to other embodimentshaving any other possible combination of the dependent features claimedbelow and those disclosed above. As such, the particular featuresdisclosed herein can be combined with each other in other manners withinthe scope of the disclosed subject matter such that the disclosedsubject matter should be recognized as also specifically directed toother embodiments having any other possible combinations. Thus, theforegoing description of specific embodiments of the disclosed subjectmatter has been presented for purposes of illustration and description.It is not intended to be exhaustive or to limit the disclosed subjectmatter to those embodiments disclosed.

The devices and techniques of the disclosed subject matter can be usedfor delivery of any of a variety of suitable fluid substances ofcorresponding volume or dose.

While the disclosed subject matter is described herein in terms ofcertain preferred embodiments, those skilled in the art will recognizethat various modifications and improvements can be made to the disclosedsubject matter without departing from the scope thereof. Moreover,although individual features of one embodiment of the disclosed subjectmatter can be discussed herein or shown in the drawings of the oneembodiment and not in other embodiments, it should be apparent thatindividual features of one embodiment can be combined with one or morefeatures of another embodiment or features from a plurality ofembodiments.

In addition to the specific embodiments claimed below, the disclosedsubject matter is also directed to other embodiments having any otherpossible combination of the dependent features claimed below and thosedisclosed above. As such, the particular features presented in thedependent claims and disclosed above can be combined with each other inother manners within the scope of the disclosed subject matter such thatthe disclosed subject matter should be recognized as also specificallydirected to other embodiments having any other possible combinations.Thus, the foregoing description of specific embodiments of the disclosedsubject matter has been presented for purposes of illustration anddescription. It is not intended to be exhaustive or to limit thedisclosed subject matter to those embodiments disclosed.

It will be apparent to those skilled in the art that variousmodifications and variations can be made in the method and system of thedisclosed subject matter without departing from the spirit or scope ofthe disclosed subject matter. Thus, it is intended that the disclosedsubject matter include modifications and variations that are within thescope of the appended claims and their equivalents.

1. A drug delivery reservoir cassette for a pump, the pump having a lockmember movable between an open position and a closed position, thecassette comprising: a cassette housing having a front surface, a backsurface and lateral sidewalls, the cassette housing defining atransverse axis extending between the lateral sidewalls and alongitudinal axis perpendicular to the transverse axis, the cassettehousing including: a cassette body region defining a fluid reservoirchamber therein, and a cassette base region having a boundary configuredto be received by the pump, the boundary including a pair of opposingrails disposed on opposite sides of the longitudinal axis.
 2. Thecassette of claim 1, wherein the pair of opposing rails aresubstantially symmetrical about the longitudinal axis.
 3. The cassetteof claim 1, wherein each of the opposing rails is recessed relative anadjacent portion of the boundary.
 4. The cassette of claim 1, whereinthe pair of opposing rails are aligned along a transverse axis relativethe longitudinal axis.
 5. The cassette of claim 4, wherein each ofopposing rails defines an abutment surface generally parallel with thetransverse axis.
 6. The cassette of claim 1, wherein the cassette baseregion includes an engagement surface configured to be engaged by thelock member when in the closed position.
 7. The cassette of claim 6,wherein the pair of rails are spaced from the engagement surface in adirection along the longitudinal axis.
 8. The cassette of claim 6,wherein the boundary includes an alignment key aligned parallel with thelongitudinal axis and defining a receiving recess to receive analignment pin from the pump.
 9. The cassette of claim 8, wherein thealignment key is spaced from the pair of rails and from the engagementsurface in a direction along the longitudinal axis.
 10. The cassette ofclaim 8, wherein the cassette further comprises a delivery tube assemblyextending from the fluid reservoir chamber, and the cassette base regionincludes a support rib projecting from the boundary in engagement withthe delivery tube.
 11. The cassette of claim 10, wherein the cassettebase region includes a flat surface proximate an end of the cassettehousing.
 12. The cassette of claim 11, wherein the flat surfacecomprises two flat surface portions.
 13. The cassette of claim 11,wherein the cassette base region includes a contoured surface configuredto mate a corresponding surface of the pump.
 14. The cassette of claim13, wherein the contoured surface has a concave shape directed towardthe boundary in plan view.
 15. The cassette of claim 13, wherein thecontoured surface is substantially symmetrical about the longitudinalaxis.
 16. The cassette of claim 1, further comprising a beneficial agentcontained in the fluid reservoir.
 17. The cassette of claim 16, whereinthe beneficial agent comprises one or more of levodopa and carbidopa.18. A drug delivery reservoir cassette for a pump, the pump having alock member movable between an open position and a closed position, thecassette comprising: a cassette housing having a front surface, a backsurface and lateral sidewalls, the cassette housing defining atransverse axis extending between the lateral sidewalls and alongitudinal axis perpendicular to the transverse axis, the cassettehousing including: a cassette body region defining a fluid reservoirchamber therein, and a cassette base region having a boundary configuredto be received by the pump, the cassette base region including anengagement surface configured to be engaged by the lock member when inthe closed position.
 19. The cassette of claim 18, wherein theengagement surface is substantially coplanar with the back surface ofthe cassette housing.
 20. The cassette of claim 18, wherein theengagement surface comprises a recessed area recessed relative the backsurface of the cassette base region.
 21. The cassette of claim 20,wherein the recessed area is shaped to receive the lock member when inthe closed position.
 22. The cassette of claim 20, wherein the recessedarea tapers to a smaller cross dimension toward an end of the cassettehousing.
 23. The cassette of claim 18, wherein the engagement surfacecomprises a pair of engagement surface portions on opposite sides of thelongitudinal axis.
 24. The cassette of claim 23, wherein the pair ofengagement surface portions are substantially symmetrical about thelongitudinal axis.
 25. The cassette of claim 18, wherein the engagementsurface comprises an elongated strip.
 26. The cassette of claim 18,wherein the engagement surface comprises a unitary bridge across thelongitudinal axis.
 27. The cassette of claim 18, wherein the boundaryincludes an alignment key aligned parallel with the longitudinal axisand defining a receiving recess to receive an alignment pin from thepump.
 28. The cassette of claim 27, wherein the cassette furthercomprises a delivery tube assembly extending from the fluid reservoirchamber, and the cassette base region includes a support rib projectingfrom the boundary in engagement with the delivery tube.
 29. The cassetteof claim 28, wherein the support rib is disposed proximate theengagement surface.
 30. The cassette of claim 28, wherein the cassettebase region includes a flat surface proximate an end of the cassettehousing.
 31. The cassette of claim 30, wherein the flat surfacecomprises two flat surface portions.
 32. The cassette of claim 31,wherein the engagement surface comprises a bridge portion joining thetwo flat surface portions.
 33. The cassette of claim 28, wherein thecassette base region includes a contoured surface configured to mate acorresponding surface of the pump.
 34. The cassette of claim 18, furthercomprising a beneficial agent contained in the fluid reservoir.
 35. Thecassette of claim 34, wherein the beneficial agent comprises one or moreof levodopa and carbidopa.
 36. A drug delivery reservoir cassette for apump, the pump having a lock member movable between an open position anda closed position, the cassette comprising: a cassette housing having afront surface, a back surface and lateral sidewalls, the cassettehousing defining a transverse axis extending between the lateralsidewalls and a longitudinal axis perpendicular to the transverse axis,the cassette housing including: a cassette body region defining a fluidreservoir chamber therein, and a cassette base region having a boundaryconfigured to be received by the pump, the boundary including analignment key aligned parallel with the longitudinal axis and defining areceiving recess to receive an alignment pin from the pump.
 37. Thecassette of claim 36, wherein the alignment key is centered between thelateral side walls.
 38. The cassette of claim 36, wherein the alignmentkey projects into the boundary.
 39. The cassette of claim 36, whereinthe alignment key projects from the cassette body region into thecassette base region.
 40. The cassette of claim 36, wherein thealignment key is channel-shaped.
 41. The cassette of claim 36, whereinthe receiving recess is tapered along the longitudinal axis.
 42. Thecassette of claim 36, wherein the cassette further comprises a deliverytube assembly extending from the fluid reservoir chamber, and thecassette base region includes a support rib projecting from the boundaryin engagement with the delivery tube.
 43. The cassette of claim 42,wherein the cassette base region includes a flat surface proximate anend of the cassette housing.
 44. The cassette of claim 43, wherein thecassette base region includes a contoured surface configured to mate acorresponding surface of the pump.
 45. The cassette of claim 36, furthercomprising a beneficial agent contained in the fluid reservoir.
 46. Thecassette of claim 45, wherein the beneficial agent comprises one or moreof levodopa and carbidopa.
 47. A drug delivery reservoir cassette for apump, the pump having a lock member movable between an open position anda closed position, the cassette comprising: a cassette housing having afront surface, a back surface and lateral sidewalls, the cassettehousing defining a transverse axis extending between the lateralsidewalls and a longitudinal axis perpendicular to the transverse axis,the cassette housing including: a cassette body region defining a fluidreservoir chamber therein, and a cassette base region having a boundaryconfigured to be received by the pump, wherein the cassette furthercomprises a delivery tube assembly extending from the fluid reservoirchamber, and the cassette base region includes a support rib projectingfrom the boundary in engagement with the delivery tube.
 48. The cassetteof claim 47, wherein the support rib comprises a pair of support ribportions.
 49. The cassette of claim 47, wherein the delivery tubeassembly includes a pair of end fittings to receive a peristaltic tube,and further wherein the support rib is substantially aligned between thepair of end fittings.
 50. The cassette of claim 47, wherein the cassettebase region includes a flat surface proximate an end of the cassettehousing.
 51. The cassette of claim 50, wherein the cassette base regionincludes a contoured surface configured to mate a corresponding surfaceof the pump.
 52. The cassette of claim 47, further comprising abeneficial agent contained in the fluid reservoir.
 53. The cassette ofclaim 52, wherein the beneficial agent comprises one or more of levodopaand carbidopa.
 54. A device for delivering a beneficial agent,comprising: a pump including a pump housing containing a pump assemblyhaving a fluid drive component, the pump housing having a receivingregion disposed proximate the fluid drive component; and a cassetteincluding a cassette housing having a front surface, a back surface andlateral sidewalls, the cassette housing defining a transverse axisextending between the lateral sidewalls and a longitudinal axisperpendicular to the transverse axis, the cassette housing including: acassette body region defining a fluid reservoir chamber therein, and acassette base region having a boundary configured to be received by thereceiving region, the boundary including a pair of opposing railsdisposed on opposite sides of the longitudinal axis.
 55. The device ofclaim 54, wherein the pair of opposing rails are substantiallysymmetrical about the longitudinal axis.
 56. The device of claim 54,wherein each of the opposing rails is recessed relative an adjacentportion of the boundary.
 57. The device of claim 54, wherein the pair ofopposing rails are aligned along a transverse axis relative thelongitudinal axis.
 58. The device of claim 57, wherein each of opposingrails defines an abutment surface generally parallel with the transverseaxis.
 59. The device of claim 54, wherein the cassette base regionincludes an engagement surface configured to be engaged by the lockmember when in the closed position.
 60. The device of claim 59, whereinthe pair of rails are spaced from the engagement surface in a directionalong the longitudinal axis.
 61. The device of claim 59, wherein theboundary includes an alignment key aligned parallel with thelongitudinal axis and defining a receiving recess to receive analignment pin from the pump.
 62. The device of claim 61, wherein thealignment key is spaced from the pair of rails and from the engagementsurface in a direction along the longitudinal axis.
 63. The device ofclaim 61, wherein the device further comprises a delivery tube assemblyextending from the fluid reservoir chamber, and the cassette base regionincludes a support rib projecting from the boundary in engagement withthe delivery tube.
 64. The device of claim 61, wherein the cassette baseregion includes a flat surface proximate an end of the cassette housing.65. The device of claim 64, wherein the flat surface comprises two flatsurface portions.
 66. The device of claim 64, wherein the cassette baseregion includes a contoured surface configured to mate a correspondingsurface of the pump.
 67. The device of claim 66, wherein the contouredsurface has a concave shape directed toward the boundary in plan view.68. The device of claim 66, wherein the contoured surface issubstantially symmetrical about the longitudinal axis.
 69. The device ofclaim 54, further comprising a beneficial agent contained in the fluidreservoir.
 70. The device of claim 69, wherein the beneficial agentcomprises one or more of levodopa and carbidopa.